Given how serious a problem Not of Standard Quality (NSQ, or sub-standard) is—a clutch of studies puts the former at between 4% and 10% of the total drug supply in the country—the government looking to join the Pharmaceutical Inspection Cooperation Scheme (PIC/S) should seem welcome. Under PIC/S— a non-binding arrangement adopted by drug regulators of 52 nations, including the US FDA—members work towards harmonising inspection standards in drug manufacturing within a broad framework of standards called Good Manufacturing Practices (GMP).
A uniform inspection system will mean greater harmonisation in standards adopted in manufacturing for the export and domestic markets. In fact, the US, a large market for Indian pharma exports, uses the GMP to judge manufacture, processing, packing or holding and determine if a drug is substandard while the Indian regime relies on a set of standards established by the Indian Pharmacopoeia that focuses on testing only the end-product. Not surprisingly, US FDA approved facilities have also faced FDA censure in the past with regards to drug quality. More important, it will also take care of another serious problem that Ranbaxy whistleblower Dinesh Thakur has highlighted in the past: India’s federal drug regulation means that there is no nationwide recall of a sub-standard drug and states alone can revoke or suspend production licence. This has meant sub-standard drugs slip into the market in others states even as the state of manufacture is in the process of testing it. But merely adopting PIC/S won’t do if the law on which Indian drug regulation is founded, the Drug and Cosmetics Act, is not amended to provide the legal backbone to GMP implementation. Equally important is tackling the problem of shortage of personnel in the inspection regime. The Mashelkar committee had recommended that India have one drug inspector for every manufacturing unit and one per 200 chemists—this means the country requires over 3,200 drug inspectors against just 900 it has today (and that is against a sanctioned strength of 1,349). A uniform inspection regime will mean little if there are not enough inspectors to enforce it.
